- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00048035
A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia
October 26, 2016 updated by: Hoffmann-La Roche
An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Intravenous Epoetin Alfa to Maintenance Treatment With Intravenous RO0503821 in Hemodialysis Patients With Chronic Renal Anemia.
This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin.
The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35211
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California
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Los Angeles, California, United States, 90095
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Illinois
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Maywood, Illinois, United States, 60153
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Kentucky
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Louisville, Kentucky, United States, 40202-1718
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Michigan
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Detroit, Michigan, United States, 48236
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Detroit, Michigan, United States, 48202-2689
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Minnesota
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Brooklyn Center, Minnesota, United States, 55430
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Nevada
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Las Vegas, Nevada, United States, 89106
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New Jersey
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Paterson, New Jersey, United States, 07503
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New York
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Brooklyn, New York, United States, 11203
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Mineola, New York, United States, 11501
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New York, New York, United States, 10128
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Tennessee
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Nashville, Tennessee, United States, 37232
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West Virginia
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Morgantown, West Virginia, United States, 26506
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- on hemodialysis therapy for at least 3 months;
- receiving iv epoetin alfa during the 2 weeks prior to the run-in period.
Exclusion Criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1 (RO0503821 [0.25/150 1x/week])
Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
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Differing doses and frequencies of iv administration
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Experimental: Cohort 2 (RO0503821 [0.25/150 1x/2week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
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Differing doses and frequencies of iv administration
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Experimental: Cohort 3 (RO0503821 [0.4/150 1x/week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
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Differing doses and frequencies of iv administration
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Experimental: Cohort 4 (RO0503821 [0.4/150 1x/2week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
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Differing doses and frequencies of iv administration
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Experimental: Cohort 5 (RO0503821 [0.6/150 1x/week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
|
Differing doses and frequencies of iv administration
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Experimental: Cohort 6 (RO0503821 [0.6/150 1x/2week])
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks.
After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
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Differing doses and frequencies of iv administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
Time Frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
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Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported.
For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks.
Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1).
For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion.
For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
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From Baseline (Day -28 to Day 1) to EOIT (Week 19)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
Time Frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
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Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported.
Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1).
For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion.
For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
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From Baseline (Day -28 to Day 1) to EOIT (Week 19)
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Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
Time Frame: Up to Week 126
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An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.
).
The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period.
As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.
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Up to Week 126
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Number of Participants With Marked Laboratory Abnormalities
Time Frame: Up to Week 126
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Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant.
The number of participants with marked lab abnormality across treatment groups were reported and presented.
Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10^9/L), Platelets (100 - 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 - 220 U/L), Aspartate aminotransferase (ASAT) (0 - 80 U/L), Albumin >= 30 g/L, Phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], Potassium (2.9 - 5.8 mmol/L), Glucose (2.80 - 11.10 mmol/L).
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Up to Week 126
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Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
Time Frame: From Baseline (Day -28 to Day 1) to Week 126
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Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value.
Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1).
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From Baseline (Day -28 to Day 1) to Week 126
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Mean Change in Pulse Rate
Time Frame: Up to Week 126
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Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles).
The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported.
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Up to Week 126
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
October 24, 2002
First Submitted That Met QC Criteria
October 24, 2002
First Posted (Estimate)
October 25, 2002
Study Record Updates
Last Update Posted (Estimate)
December 20, 2016
Last Update Submitted That Met QC Criteria
October 26, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BA16285
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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